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Proactive Community Case Management (Pro-CCM) in Rural Madagascar (Pro-CCM)

24. Januar 2022 aktualisiert von: Rila Ratovoson, Institut Pasteur de Madagascar

Randomized Cluster Trial to Measure the Effectiveness of Home Care in Hyperendemic Rural Areas in Madagascar

The trial took place in a rural area hyper endemic for malaria, the hypothesis of which was that active detection and treatment of malaria in the population (all ages combined) in the event of a positive test could reduce the prevalence of malaria in the region. zoned. It was a two-armed, randomized, cluster-based community intervention trial:

  • one arm with home treatment of malaria for the duration of the study for patients with a positive result in the rapid diagnostic test for malaria.
  • a control arm with the usual malaria management procedures (ie consultation with community workers or the nearest health centers in the event of fever or suspected signs of malaria).

Before the start of monitoring, an initial survey (Baseline) was carried out in the "fokontany" (villages / cluster) included in the 2 arms, in order to determine the prevalence of malaria. Then, in the intervention arm, screening for malaria by RDT every 2 weeks in subjects with a suspected malaria case (fever or notion of fever in the 2 days preceding the visit) and treatment with Artesunate-amodiaquine (ACT) for patients with a positive RDT. At the end of the follow-up period, a final survey (Endline), based on the same questionnaires as during the Baseline, was carried out in the 2 villages of the 2 arms.

As a secondary objective, a study on anemia in women aged between 15 and 49 years was also carried out during the baseline and endline periods in order to compare the prevalence between the 2 periods

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study aims to compare the prevalence of malaria in the rural community of Mananjary after the Malaria Home Care Program (PECADOM Plus).

The study will take place in fokontany rural communes of the district of Mananjary.

This district was chosen for the following reasons:

  • High prevalence of malaria in this area (31% in subjects with fever and attending medical consultation in the CSB included in the sentinel IPM fever site)
  • presence of Peace Corps Volunteers (PCV) in this district. Mananjary District is situated in southeastern Madagascar, located in the central part of the Vatovavy Fitovinany Region, in the province of Fianarantsoa. It is located at 21°13'52" South and 48°20'31" East. The district is composed of one urban commune and 28 rural communes. After obtaining the agreement of the ethics committee for the realization of the study, the coordinator or the assistant coordinator of the project will make courtesy visits to all administrative and health officials in the Vatovavy Fitovinany and Mananjary District (Regional Directorate, District Chief ...).A random draw of fokontany meeting the inclusion criteria will be carried out later, to identify the distribution of fokontany in the intervention arm and control arm in the project. In addition to the 22 fokontany required, a draw of 8 reserve fokontany will be made (4 for each arm).

A courtesy visit will be conducted in the fokontany raffled. The coordinator will check the number of inhabitants in these fokontany with the information gathered at the time of the preparation of the protocol (projection of the population according to the data of INSTAT, information from the Medical Inspector of Mananjary). If the fokontany will not be eligible, the reserve fokontany will replace them in the study.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

1000

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Madagaskar
    • : Fianarantsoa, Vatovavy Fitovinany
      • Mananjary, : Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Andranomavo
    • Fianarantsoa, Vatovavy Fitovinany
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Ambakoana
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Ambalamanasa
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Ambalaromba
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Ambinany Namorona
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Amboditandroho
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Ambohimiarina II
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Ambohinihaonana
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Ambolotara
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Andranomiteka
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Anilavinany
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Ankazotokana
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Anosimparihy
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Kianjavato
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Mahavoky Sud
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Manotro
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Maroamboka
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Sahafotahina
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Sandravakoka
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Tanambao Sud
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Tanambaobe
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagaskar, 317
        • Fokontany Tsarahafatra

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

2 Monate und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Inclusion criteria in community:

    • Fokontany in rural communes of Mananjary district (fokontany level of safety, accessibility by the study teams, and phone network availability was assessed).
    • Agreement of the chief of Fokontany for the participation of his fokontany in the study
    • Fokontany with at least 1,000 inhabitants

  • Individual inclusion criteria:

    • Resident in the relevant areas during the study period and consenting to participate

Exclusion Criteria:

  • Exclusion criteria in community:

    • Fokontany with a total population of less than 1000 inhabitants
    • Fokontany in an urban commune
    • Fokontany in an area whose access is risky and perilous
  • Individual exclusion criteria:

None (Non-resident present at the time of passage were tested in the study if they have suggestive signs of malaria but they were considered as visitors)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intervention fokontany
Verhalten: Proactive community case management
CHWs in the intervention arm conducted door-to-door fever screening for all inhabitants of all consenting households in their catchment area every fortnight. All individuals with temperature ≥ 37.5°C or history of self-reported fever in the previous two weeks were tested with an RDT; positive individuals who were not pregnant and did not have signs of severe disease were treated with artesunate-amodiaquine according to treatment guidelines. Individuals identified as requiring a referral during Pro-CCM visits were assisted with transfer to the healthcare center, with transportation handled by the project staff.
Kein Eingriff: Control fokontany

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
Zeitfenster: an average of 1 year
Difference in differences (DiD) approach comparing baseline to endline is used to compare the prevalence of malaria RDT positivity in the 2 arms
an average of 1 year

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
percent of households visited every two weeks
Zeitfenster: The event was assessed up to 30 weeks (15 biweekly visits).
percent of households visited every two weeks out of the number of the households registered in initial census
The event was assessed up to 30 weeks (15 biweekly visits).
percent of households gave consent
Zeitfenster: The event was assessed up to 30 weeks (15 biweekly visits).
percent of households that were visited every two weeks and gave consent for the screening during each visit
The event was assessed up to 30 weeks (15 biweekly visits).
Fever incidence
Zeitfenster: The event was assessed up to 30 weeks (15 biweekly visits).
percent of fever cases out of all individuals screened during each visit
The event was assessed up to 30 weeks (15 biweekly visits).
Malaria incidence
Zeitfenster: The event was assessed up to 30 weeks (15 biweekly visits).
percent of persons with positive RDT and fever cases out of all individuals screened during each visit
The event was assessed up to 30 weeks (15 biweekly visits).
fever cases with RDT performed
Zeitfenster: The event was assessed up to 30 weeks (15 biweekly visits).
percent of fever cases with RDT performed
The event was assessed up to 30 weeks (15 biweekly visits).
RDT-positive persons treated with an ACT
Zeitfenster: The event was assessed up to 30 weeks (15 biweekly visits).
percent of RDT-positive persons treated with an ACT during each visit
The event was assessed up to 30 weeks (15 biweekly visits).
The change in the prevalence of anemia in women aged between 15 and 49 years old in the intervention versus control fokontany
Zeitfenster: an average of 1 year
Difference in differences (DiD) approach comparing baseline to endline is used to compare the prevalence of anemia in the 2 arms
an average of 1 year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Institut Pasteur de Madagascar

Mitarbeiter

United States Agency for International Development (USAID)
Peace Corps
National Malaria Control Programme, Madagascar

Ermittler

  • Hauptermittler: Rila Ratovoson, MD, Institut Pasteur de Madagascar
  • Studienleiter: Milijaona Randrianarivelojosia, PhD, Institut Pasteur de Madagascar

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. Dezember 2016

Primärer Abschluss (Tatsächlich)

12. Dezember 2016

Studienabschluss (Tatsächlich)

29. Dezember 2018

Studienanmeldedaten

Zuerst eingereicht

10. Januar 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Januar 2022

Zuerst gepostet (Tatsächlich)

4. Februar 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Februar 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Januar 2022

Zuletzt verifiziert

1. Januar 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2017-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

All IPD that underlie results in a publication

IPD-Sharing-Zeitrahmen

Some summary data are available from December 2021; and some data at the time of publication (2022)

IPD-Sharing-Zugriffskriterien

IPD and any additional supporting information will be shared in supplementary files in publication and via Harvard Dataverse

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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